Clinical trials play a vital role in advancing patient treatment and medical care. Their significance continues to rise as our understanding of diseases expands. This article delves into ten trends and statistics in the world of clinical trials for 2023.
And don’t forget to explore the upcoming webinars about clinical trials on Xtalks to see what piques your curiosity about the latest clinical trial solutions.
1. Increasing Number of Registered Clinical Trials
As of May 17, 2023, there are 452,604 registered clinical trials globally on ClinicalTrials.gov. Of the total registered studies, 64,838 are actively recruiting participants. This represents a significant increase from the over 365,000 registered trials reported in early 2021. It is clear that the clinical research landscape continues to expand at a substantial rate.
The growth in the number of registered studies can be attributed to various factors such as: advancements in medical technology; an increase in the number of diseases being studied; the rise of personalized medicine; and the need for new treatments and vaccines, especially in response to global health crises like the COVID-19 pandemic.
2. Global Distribution of Trials
Clinical trials are conducted all over the world and their distribution is influenced by a variety of factors including disease prevalence, the regulatory environment, population demographics, healthcare infrastructure and cost.
Clinical trials are increasingly becoming a global endeavor. As of May 2023, more than half (53% percent) of all registered studies are conducted outside the US, while 31 percent are conducted exclusively within the US and five percent involve both US and non-US locations. This highlights the international collaboration in the pursuit of medical advancement.
When we look at the countries contributing to clinical trials from 2015 to 2019, the US led with 35 percent of the participants. Following the US, Poland, Germany and Russia each contributed four percent of the participants, and Japan, Canada and Czechia each contributed three percent. Other countries like Ukraine, France, India, the United Kingdom, Spain, Hungary, Italy, Brazil, Argentina, Romania, Bulgaria, South Korea and China each contributed one to two percent of the participants.
3. Types of Registered Studies
According to ClinicalTrials.gov, as of May 2023, 77 percent of registered studies are interventional, with a significant portion of these focusing on drugs or biologics (181,721 studies or around 40 percent of all trials) and a smaller portion on devices (46,809 studies or around 10 percent of all trials).
Additionally, there are 101,969 observational studies (around 22.5 percent of all trials), underscoring the importance of both interventional and observational research in understanding health and disease.
Lastly, a small number of trials (888) are categorized as “Expanded Access,” which refers to the use of a medical product outside of a clinical trial to treat a patient with a serious disease or condition who has no comparable or satisfactory alternative treatment options.
4. Growing Complexity of Clinical Trials
Research teams are increasingly dealing with complex clinical trial designs and clinical research complexity. For example, between 2001 to 2005, there was an average of 31 eligibility criteria per trial, while between 2011 to 2015 the average number of eligibility criteria was 50; this represents a rise in complexity of 61 percent. In addition, the number of endpoints in a trial protocol has increased by 86 percent from 2001 to 2015, making the planning and testing process more challenging.
According to the Bain Clinical Trials Voice of Customer Survey, 2022, 56 percent of sites say trials are more complex than just three years ago.
This complexity has led to the rise of clinical research organizations (CROs), which provide specialist support at specific phases of the drug development process.
5. Large Number of Drugs in the R&D Pipeline
There are over 20,109 drugs in the R&D pipeline as of 2022, showing the vast scale of ongoing efforts to develop new treatments for various disease conditions. For comparison, there were 18,582 drugs in the R&D pipeline at the same time in 2021, and 5,995 drugs during 2001.
This growing number reflects the use of new technologies such as artificial intelligence (AI) and machine learning in drug discovery and development. These technologies can hopefully identify promising drug candidates more efficiently and reduce the risk of failure in later clinical stages by predicting a drug candidate’s behavior in the human body; however, these technologies also add to the cost and complexity of drug development, which are already high.
6. Rising Cost of Drug Development
Developing a new drug is an expensive venture. As of 2023, the total cost of developing a drug in the US stands at around $2.6 billion. This figure emphasizes the substantial financial investment needed to bring a new treatment to market.
On average, it takes 10 to 15 years to develop a new drug. During this time, pharmaceutical companies must invest heavily in R&D and clinical trials without any guarantee of a return on their investment. This prolonged period of investment without income contributes to the high cost of new drugs.
Even after a drug is approved, pharmaceutical companies are often required to conduct further studies to monitor the long-term effects of the drug in the wider population. This post-marketing surveillance can reveal side effects that were not evident in the clinical trials and can result in a drug being withdrawn from the market. The cost of this ongoing research adds to the overall cost of drug development.
7. Breakdown of Trials by Phase of Development
As of May 19, 2023, the ClinicalTrials.gov database had the following number of studies registered for each clinical phase of development:
- Early Phase I/Phase I: 58,207 clinical studies (28 percent)
- Phase II: 74,432 clinical studies (36 percent)
- Phase III: 42,947 clinical studies (21 percent)
- Phase IV: 30,894 clinical studies (15 percent)
The other clinical studies on ClinicalTrials.gov had “Not Applicable” registered as their phase.
According to the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP), in February 2023, out of 271,906 clinical trials in a known phase of clinical development, 19 percent were in Phase I, 35 percent were in Phase II, 28 percent in Phase III and the remaining 18 percent of trials were in Phase IV.
8. Percentage of Trials Completed
The completion rates for all clinical trials from Phase I to Phase IV were estimated to be around 91.4 percent, 81.1 percent, 84.9 percent and 87.2 percent, respectively, in 2018; however, it is important to note that the completion of a clinical trial does not mean that the drug or device was found to be successful. For example, the observed clinical study success rates from academic drug discovery and development between 1991 and 2015 in the US were 75 percent at Phase I, 50 percent at Phase II and 59 percent at Phase III.
In addition, a report from 2019 indicated that more than 30 percent of drugs entering Phase II trials don’t progress, and over 58 percent of drugs fail in Phase III trials.
Furthermore, a study published in 2018 found that oncology drugs have the lowest clinical trial success rate at only 3.4 percent. On the other hand, vaccines for infectious diseases have a 33.4 percent clinical trial success rate, which is the highest of all therapeutic areas.
9. Clinical Trials by Therapeutic Area
The top ten therapy areas from 2017 to 2022 ranked by the number of clinical trials worldwide are:
- Oncology (24 percent)
- Infectious disease (12 percent)
- Neurology (ten percent)
- Hematology (eight percent)
- Endocrinology (six percent)
- Respiratory (five percent)
- Dermatology (five percent)
- Cardiovascular (four percent)
- Psychiatry (four percent)
- Ophthalmology (three percent)
It is no surprise that oncology drugs are the most highly evaluated therapies in clinical trials worldwide.
10. The Rising Role of CROs
The global market for contract research outsourcing was estimated at $49.8 billion in 2022, and is anticipated to reach $90.4 billion by 2030 at a compound annual growth rate (CAGR) of 7.7 percent.
More and more pharmaceutical and biotech companies are outsourcing their R&D activities to CROs. This is driven by several factors including access to specific expertise, cost reduction and the ability to scale operations more flexibly.
Here are some key trends about the CRO industry for 2023 and beyond:
- Efficiency improvement and structural reform: In recent years, there has been a noticeable emphasis on improving operational efficiencies among research entities, including CROs. This pattern is set to persist into 2023. To tackle site capacity issues, CROs are focusing on integrating advanced technologies and fostering collaborative research alliances with both sponsors and service providers.
- Talent management and expertise: There’s a strong demand for research specialists, a trend that will sustain in 2023. It will be crucial for CROs to handle staff turnover effectively and train new recruits and less experienced research personnel.
- Targeting emerging markets: CROs are broadening their reach on an international scale, particularly targeting rising markets like India and China. These locations present affordable operational costs and vast groups of potential participants for clinical trials.
- Technology incorporation: To improve the efficiency of clinical trials, CROs are progressively integrating advanced technologies into their methodologies. The implementation of AI, data analytics and digital health technologies is seen as a way to enhance data compilation, patient recruitment and trial surveillance.
- Mergers and acquisitions: There’s a notable shift towards consolidation within the CRO sector, as larger CROs acquire smaller ones to broaden their array of services and extend their geographic influence.
- Strategic alliances and partnerships: Moving beyond mere contractual dealings, pharmaceutical firms are increasingly engaging in long-lasting strategic alliances with CROs. This shift fosters improved cooperation and mutual alignment of objectives.
CROs are a critical part of the clinical trial landscape, and their influence and responsibilities for clinical trials will likely increase in the years to come.
Be sure to check out the latest Xtalks webinars on clinical trials to see how CROs are overcoming the latest challenges in clinical research.